ADR that result in revision of patient information
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| Updates on the use of ketoconazole |
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1. European Union: European Medicines Agency recommends suspension of marketing authorisations for oral ketoconazole
The European Medicines Agency’s Committee on Medicinal Products for Human Use (CHMP) has recommended that the marketing authorisations of oral ketoconazole-containing medicines should be suspended throughout the European Union (EU). The CHMP concluded that the risk of liver injury is greater than the benefits in treating fungal infections.
Patients currently taking oral ketoconazole for fungal infections should make a non-urgent appointment with their doctor to discuss suitable alternative treatments. Doctors should no longer prescribe oral ketoconazole and should review patients’ treatment options.
The EU-wide review of oral ketoconazole was triggered by the suspension of the medicine in France. The French medicine agency, the National Agency for the Safety of Medicine and Health Products (ANSM), concluded that the benefit-risk balance of oral ketoconazole was negative because of a high level of liver injury associated with the medicine and in view of the currently available alternative treatments, which are deemed to be safer. European legislation requires that there is a coordinated European approach when a Member State takes regulatory action in relation to a medicine that is authorised in more than one country.
Having assessed the available data on the risks with oral ketoconazole, the CHMP concluded that, although liver injury such as hepatitis is a known side effect of antifungal medicines, the incidence and the seriousness of liver injury with oral ketoconazole were higher than with other antifungals. The CHMP was concerned that reports of liver injury occurred early after starting treatment with recommended doses, and it was not possible to identify measures to adequately reduce this risk. The Committee also concluded that the clinical benefit of oral ketoconazole is uncertain as data on its effectiveness are limited and do not meet current standards, and alternative treatments are available.
Taking into account the increased rate of liver injury and the availability of alternative antifungal treatments, the CHMP concluded that the benefits did not outweigh the risks. Topical formulations of ketoconazole (such as creams, ointments and shampoos) can continue to be used as the amount of ketoconazole absorbed throughout the body is very low with these formulations.
Please refer to the following websites for details:http://www.ema.europa.eu/../news_detail_001855.jsp&mid=WC0b01ac058004d5c1
2. United Kingdom: Press release: Oral ketoconazole-containing medicines should no longer be used for fungal infections
The related news was also reported at Medicines and Healthcare Products Regulatory Agency (MHRA) website. MHRA advised that patients on these medicines should make a non-urgent appointment with their doctor to discuss alternative treatment.
Please refer to the following websites for details:http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON297530
3. United States: Food and Drug Administration limits usage of Nizoral (ketoconazole) oral tablets due to potentially fatal liver injury and risk of drug interactions and adrenal gland problems
The U.S. Food and Drug Administration (FDA) is taking several actions related to Nizoral (ketoconazole) oral tablets, including limiting the drug’s use, warning that it can cause severe liver injuries and adrenal gland problems and advising that it can lead to harmful drug interactions with other medications. FDA has approved label changes and added a new Medication Guide to address these safety issues. As a result, Nizoral oral tablets should not be a first-line treatment for any fungal infection. Nizoral should be used for the treatment of certain fungal infections, known as endemic mycoses, only when alternative antifungal therapies are not available or tolerated.
The topical formulations of Nizoral have not been associated with liver damage, adrenal problems, or drug interactions. These formulations include creams, shampoos, foams, and gels applied to the skin, unlike the Nizoral tablets, which are taken by mouth.
FDA will continue to evaluate the safety of Nizoral tablets and will communicate with the public again if additional information becomes available.
Please refer to the following websites for details:http://www.fda.gov/Safety/MedWatch/../ucm362672.htm
In Hong Kong, there are 24 oral ketoconazole-containing registered pharmaceutical products and they are all prescription-only medicines. Related news had been released by China Food and Drug Administration and Health Canada and they were posted on the Drug Office website on 1 September 2011 and 20 June 2013 respectively. Letter to inform healthcare professionals to draw their attention on the issue and urge them to report adverse drug reactions related to oral ketoconazole was issued on 1 September 2011. The matter was discussed by the Registration Committee (the Committee) of the Pharmacy and Poisons Board in February 2012 and the Committee decided that Drug Office should keep vigilant on this safety issue. In light of the latest recommendations from European Medicines Agency, Medicines and Healthcare products Regulatory Agency and United States Food and Drug Administration, a letter to inform healthcare professionals will be issued and the matter will be further discussed by the Committee.
Ends/ Saturday, July 27, 2013
Issued at HKT 12:00
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